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Although double-blind studies have recently been conducted with chasteberry, uncontrolled trials go back to the 1940s when a product known as Agnolyt was tested. The product was developed and patented by Dr Gerhard Madaus in Germany and contained Vitex agnus-castus. Several different vitex products have been investigated to date including: Agnolyt (standardised to 3.5-4.2 mg of dried chasteberry extract), Vitex agnus-castus L. extract Ze 440 (each 20 mg tablet standardised for casticin and agnuside), Femicur (contans 1.6-3.0 mg of dried extract per capsule) and Mastodynon (53% v/v ethanol) a homeopathic preparation.

Owing to difficulty in locating the German studies, secondary information sources have sometimes been used to provide a more comprehensive review. PREMENSTRUAL SYNDROME

Chasteberry relieves some common symptoms associated with PMS, according to several clinical trials (Atmaca et al 2003, Berger et al 2000, Dittmar 1992, Lauritzen 1997, Loch et al 2000, Schellenberg 2001). According to these clinical trials, the PMS symptoms that respond best to treatment are breast tenderness, irritability, depressed mood, anger, mood changes, headache and constipation. The most studied extract investigated in PMS is Ze440 (see Clinical note below).

A multicentre, randomised, controlled, double-blind study investigating the effects of Vitex (Ze 440) for PMS involved 170 women and was published in the British Medical Journal (Schellenberg 2001). Of the group, 13% were also taking OCP. Treatment with a 20 mg tablet of dry extract of chasteberry taken daily resulted in a significant improvement of PMS symptoms, particularly headache, breast fullness, irritability, anger and mood changes. Over 50% of women in the active treatment group achieved at least a 50% reduction in symptoms.

Previously, a number of open studies had generally produced positive results for vitex as a symptomatic treatment in PMS. One multicentre open-label study showed that daily treatment with a 20 mg tablet of Vitex (Ze 440) over three menstrual cycles significantly reduced the Moor menstrual distress self-assessment questionnaire

(MMDQ) with 46% of women experiencing a 50% reduction in the MMDQ. Treatment also reduced the duration of PMS symptoms from 7.5 days to 6 days and was as effective for women taking OCP as for those who were not (Berger et al 2000) Once treatment was stopped, PMS symptoms gradually returned to baseline within three further cycles. The largest multicentre trial was an open study of 1634 women with PMS, which found that treatment with vitex (Femicur) for three menstrual cycles decreased the number of PMS symptoms in 93% of subjects (Loch et al 2000). Symptoms completely resolved in 40% of subjects and 94% overall rated vitex treatment as well tolerated. An early study using vitex (Agnolyt) in 1 542 women with PMS reported an improvement in symptoms with an average dose of 42 drops daily taken for an average of 25 days (Dittmar 1992 as reported in Ulbricht & Basch 2005). According to Ulbricht and Basch (2005), three earlier uncontrolled studies produced inconclusive results.

Although vitamin B6 is a popular treatment for PMS symptoms, the results from a double-blind comparative study have found that vitex (Agnolyt) is as effective and possibly more so (Lauritzen et al 1997). The randomised, double-blind study of 175 women compared vitex, pyridoxine and placebo. In the study, 77% of women receiving vitex reported symptom alleviation compared with 61% with pyridoxine (200 mg/day), which was considered a small but significant difference. Additionally, physician assessments were more likely to rate treatment with vitex as 'excellent' compared with pyridoxine.

In 2003, a randomised 8 week study involving 42 women compared the effects of 20-40 mg daily of fluoxetine, a SSRI, and 20-40 mg of vitex extract and found no statistically significant difference between the groups with respect to the rate of responders (Atmaca et al 2003). More specifically, patients with premenstrual dysphoric disorder responded well to both treatments; however, fluoxetine was more effective for psychological symptoms such as depression and irritability whereas the herbal extract was more effective for diminishing physical symptoms such as breast tenderness, cramps, food cravings and swelling. Unfortunately, the authors did not report the type of vitex extract used in the study.

Commission E approves the use of chasteberry for this indication.

Clinical note — Ze440 extract

The naming of the Ze440 extract (Premular in Australia) is derived from the name Zeller, the 135-year-old Swiss company manufacturing it, combined with a unique number ascribed during the initial studies. In order to ensure that products deliver consistent results, Ze440 is measured by both composition and consistency from batch to batch. To promote product uniformity, every batch is grown, harvested © 2007 Elsevier Australia

and manufactured into tablets under controlled conditions and Is extracted In a standardised method that ensures consistent and high levels of the Important lipophilic compound castlcln and an established marker compound, the Irldold glycoside named agnuslde.

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